Tips on having an FDA inspection
Started by Simon, Aug 18 2023 07:06 PM
Tips on having an FDA inspection
Took Place:
Friday, August 25, 2023
Presenter:
Earl Arnold, Manager and a Food Defense Subject Matter Expert, AIB International
Webinar Overview:
Employee shortages and supply chain disruption pose great challenges for food manufacturers, and, with the increase in regulatory scrutiny, many are struggling to get ready for their next FDA regulatory inspection. Earl Arnold, Manager at AIB, will share some tips that will help you assess if your regulatory inspection team is prepared to answer all the questions posed by an FDA investigator.
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Chat logs from today's webinar:
Allan De Guzman : Hi from the Philippines!!!
Karla Albuquerque : Hi from Massachusetts
Nadia Saenz Saenz : Hello from Meriden, CT, USA!!
KIPKOECH GEOFFREY GEOFFREY : Hi
Marino Dait : Hello everyone, from PHL
Mayank K Joshi : Hi it's Mayank from India
Barbara Bielecki : Good morning from Australia
Martin Núñez Nunez : Hi everyone from Venezuela
Toni Widger : Good morning from IL
Muszalina Mustafa : Hi from penang, Malaysia
Rakesh Patel : Hi from India
Kris Young : Hello from Kansas!
Nurul : hi from Malaysia
John Roger B. Falcasantos : hi
Ana Lucas : Hello!!
Abbi Howe : Good morning, from Alabama, USA
Lampros Michas : Hello from Greece
PREM SAGAR : Good evening from INDIA!
Arianna Contardi : Hello from Italy! 🌞
Elaine WU : Hi from Missouri, USA!
SHANEKA Ricks : Hello from Delawere
Murali Murthy kosaraju m : Hi Murali From KSA NADA
Jeanne Gannon : Hi From St. Louis, MO USA
Djamel : Hi, Djamal Mahdaoui from Algeria
Shivam Pandey : Hi from oman
Ashok Kundaliya Kundaliya : Hi Ashok from India
Karen Peligrino : Hello from Salem, Oregon USA
Leonard : Hello from Eugene, Oregon USA
Santosh Sharma : Hi....everybody
Ana Lucas : hello
Gareth : Good afternoon from Liverpool, UK
Muhammad Yunas : Hello to everyone from Pakistan National Foods
EDWIN OKONG'O : Hi All from Mwanza,Tanzania
Mariana Shivacheva Shivacheva : Good morning from San Francisco, CA
Cassandra Giauque : Hello from Ohio, USA
Cindy Halbleib : Good morning
Glen Todd : Good morning from Glen California
Gavin maharaj : Good Morning from Toronto!
Philomena Afeonkhai Afeonkhai : Good morning from Winnipeg CA
Chinwendu Obi : Chi-Chi Obi Enyobi from Georgia USA
Carol Dyck : Good morning from Vancouver Canada
Olaoluwa : Hi, Phillip from NIGERIA
Sarahi : Good morning!
Mahasweta yadav : hello
geri jones : Hello from Indianapolis, IN USA
LucÃa : Hello everybody, LucÃa from Argentina
Charity : Hello
Ayushi : Good afternoon from South Africa
Ednah Mokwena : Hello from South Africa
tina Block : good morning, from Wisconsin
SarahWu : Hi, Sarah from Taiwan
Nathan : Good morning from Lester Iowa!!
Christina Gioiosa : We had a heat index of 120F in Chicago yesterday. Can't imagine a month like that
Eike : Hi from GErmany!
Stephanie Kopp : Good Morning from Lancaster, PA USA
Kayla Nelson : St. Louis MO---very hot and humid here!
Verónica Sandoval : Good morning, from Lima Perú
Charity : Hello from Kenya
MUSTAPHA KHANJARI : Hi from Morocco :)
Mohammed ARAB : hello mohammed from algerie
Sarah : Hello to all from NW Iowa, USA! Been hot & humid here, too :)
Luz Lopez : I’m from california
Matthew Creswell : Hello from Oregon, United States of America
Kim Orr : Hello from Ontario, Canada!
Liesel van Heerden : Liesel from South Africa!
Steve Thompson : Arizona, nice and hot here
Missy Blackwell : Hello from Missy on Long Island, NY!
Milynda Dosunmu : Hello from Jamaica
Edith EDITH : Hi from Paris !
Aaron : Good morning from Lester, Iowa
Mohammad Dmohasin : Mohammad Dmohasin from Pennsylvania
Simone Mills : Good morning from Jamaica!
Daniel Nyanteh : Hello, Daniel Nyanteh from Ghana.
Jan : Hello from South Carolina
Bill : Bill from Indiana
Eva VILLARREAL : Hi Eva Villarreal from AIB International Mexico
Mark Reyes : Good morning from West Texas!
Kalpesh : Hello all, Kalpeshh Dallvi from INDIA
Barb Tande Tande : Hi form Finley ND
Osama kamal : Good afternoon
Dora Silva : Good afternoon from Portugal
Cristina Bernal Cerino : Hello from Mexico. Here at 55 F (around 12.7 Celsius)
Eike : Hi from Germany!
Tracy : Good Morning from Waupaca Wisconsin
Melissa Andrade : Hello from CT!
Ivna : Hello!! I'm from Brazil
Erik : Hello from Western Ohio
Delara Rashidi sabet : Hi from canada
Irma Sampedro : Hi! From México
Juan Obeso : hello, Juan from Florida
Risper Kiaye : Risper Hola from Kenya
Tessa Caprio : Hello from New Jersey :)
Setu Rajyaguru : Hello, from New jersey
Ron van Dijk : Hello from Belgium
Christopher Fiyado : Good day from Johannesburg SA
Janelle Nicholas Nicholas : Good morning fro NJ
Simone Kummerlöwe : Good afternoon from northern Germany
Pratik Vasant Goregaonkar : Hi from Niagara falls
Guadalupe Santana Santana : Hello from Dominican Republic!
Sarah : PCQI trained by Earl Arnold :)
Angela : Good afternoon from Nigeria
miraj patel : englands usage of tesco sainsburys
miraj patel : englands costco usage
miraj patel : englands grocery stores learnings
miraj patel : the system discussing food safety
Angela Suarez Fajardo Suarez Fajardo : Good morning , Angela from Ecuador
Srikanth : Hello, I'm from India
miraj patel : the workplace cafetaria part one job the set up
miraj patel : the basics at workplace abnamro cafe smoothie bakerie shops items salad bars
miraj patel : next programs ticket to wokr lunch and lunch item retailer
miraj patel : food court retailer
miraj patel : the systems explanation of unit items at retailers purchased
Nataliia Kit : Hi from Ukrainian in the Netherlands!
miraj patel : what is average starbucks coffee iced cup or warm cups customers purchased after 2010
miraj patel : grocery store items
miraj patel : grocery store agencies
miraj patel : inventory
Khek Li Ling : Hi, Khek from Malaysia
miraj patel : food labelling
miraj patel : food unit items
PATRICIA GARICA Garcia : good morning from Canada
miraj patel : bakery aisles
miraj patel : frozen aisles
miraj patel : dairy
miraj patel : ice creams
miraj patel : fruits vegetables
miraj patel : food at colege
miraj patel : chain restaurant logo next used
miraj patel : chain restaurant lense
miraj patel : next i9 form nearby food retailer
miraj patel : uscis food retailer
Neneth Raggett Raggett : good morning
miraj patel : what this connected together with human resources
miraj patel : motels with breakfast
miraj patel : motels with breakfast
miraj patel : the next usda card is new color
miraj patel : its not blue
miraj patel : its new card color
miraj patel : it renewed 2 years
miraj patel : one hhs worksheets arrived mailbox yesterday
Queen Chukwunyere : Queen chukwunyere
miraj patel : wednesday the card arrived usda card
miraj patel : another hhs envelope today thats online
miraj patel : fda agencies
miraj patel : mailed from south dakota
miraj patel : usually it was mailed from texas
miraj patel : salad bar
miraj patel : whats communicating next
miraj patel : next workplace building
Queen Chukwunyere : Good evening from Qatar
Nadia Saenz Saenz : miraj patel This chat is for Food Safety only
miraj patel : franchises expanding
miraj patel : normal work week actual lunch items around area
miraj patel : wise events 100 plus months, prepare lunch at home
miraj patel : pumpkins
miraj patel : halloween candy
miraj patel : christmas items
miraj patel : where england had those christmas items
miraj patel : englands grocery store learnings
Kayalvili : Hello from Malaysia!
miraj patel : englands sainsburys tescos morrisons asda
SONU KUMAR : Good evening sir
Bruce Perkin : @ Miraj - please stop spamming us - you are not making any sense
SONU KUMAR : Hello
Stephen Bulow : Can someone cut off miraj patel.
Larbi Larbi : Hi everyone
Prem Prakash Kushwaha Prakash : Hi all
SONU KUMAR : Call me 9155490688
Kristina Lacman Čubrić : Hello from Croatia
Dea Lopez Lopez : Good Morning all
SONU KUMAR : Hello Kristina
Joanna Kucz : if I produce in UK but export to US do I have FDA inspection? and if so, how? remote inspection or in person?
Deborah Lyons-Garcia Lyons-Garcia : Good Morning, Pomona, California
Paula Ferreira : Hello from Portugal!
Muhammad Yunas : If I import from Pakistan to USA or any other countries, is this inspection is mandatory??
lalia Mantecon : Recently FDA has recognised third-party standards like SQF, BRCGS, FSSC, and GlobalGAP align with FDA regulations, how does this help during a FDA inspection? If we get an inspection can we avoid this by presenting this certification? Thanks!
Danielle Eunice de Jesus : Good day
Pete Mitchell : hello
Larbi Larbi : Why inspector did not give 482 observations after foreign factory inspection
Abd El-Rahman Ahmed El-Garhy : Is wheat flour field need fsma rules
Leonidas Mademlis : Hello.....Leonidas, Greece
Javier Diaz : Good morning from from Tracy CA
Radojka Barycki : In my experience, they do not give you room to argue when they want to take pictures. They do press hard.
ADEWALE SABITU : Wale, from Nigeria
Rajendra Patel : Myself Rajendra Patel from
Rajendra Patel : shree pest control, India
Edwin Videla : C
Bill : D
Elisabeth Metzger : When the weekly warning letters come through, it's a lot of FSVP violations.
Christina Gioiosa : B or D, I think
Tracy : D.
Christina Gioiosa : Or not ~verifying~ corrective actions perhaps
MUSTAPHA KHANJARI : what is the standard used for the FDA inspection? how can one become an FDA inspector?
Giulia Grande PhD : doyou mean 482 ?
Radojka Barycki : Yes. I saw a lot of warning letters too around FSVP last year too
Rajendra Patel : Can I pl have guidelines documents for USFDA audits for pharmaceutical industry if possible pl share in pdf on my email shreepestcontrol@gmail.com
Robert Savage : Bob Savage Greetings from Fairfax, Virginia
Phil Gao : If we don't purchase from any foreign supplier directly, we use brokers. Does FDA still require to have a foreign supplier approval program?
MUSTAPHA KHANJARI : PSQI must be carried out once or renewed each time?
Vasana Weerasinghe : How do we know we need a Food Defense Qualified Individual?
Muhammad Aslam Javaid : C
Janelle Nicholas Nicholas : C
Larbi Larbi : Did inspector need presence of process authorty
Sovann Kin : Can one FDA inspection cover both Food Safety (117) and Food Defense (121) requirements?
Adriana : Where we can find the reference of FSVP missing as the main cause of issues during an FDA inspection?
EDWIN OKONG'O : Hi from Mwanza,Tanzania
Pradeep Weerathunga : Your organization is conducting IFS Lead audit training programs
Sonia Portillo : Good Morning! Greeting from Michigan. Thank you for this excellent presentation.
Jennifer Dewitt : Good Morning! Arkansas
Radojka Barycki : Key word: documented. Ensure that you document these. I find that in many cases, sites fail to document the things they do. Remember, if it is not documented, it never happen because there is no written evidence
Jennifer Dewitt : BRC covers this as well
Radojka Barycki : Did they change the compliance date for Traceability? It was my understanding the deadline is January 20, 2026
Bill : Will this presentation be available after this webinar for our review
Giulia Grande PhD : amazing presentation, thank you! great recommendations!
Larbi Larbi : Bpcs training is it mandatory for foreign companies?
Sarah : We had an FDA inspection earlier this year. The FDA compared our Ingredient HA in our FS Plan against their Appendix 1: Potential Hazards for Food and Processes document. Highly recommend using this!
Martin Núñez Nunez : Are there courses to be certified in food Defense by th FDA?
Marlon Sequeira : Excellent presentation!!!
Ponbharathi R : Sir can you share the presentation
Muhammad Aslam Javaid : Excellent info
Sarah : We are a non-RTE bakery. What frequency of FDA visits can we expect?
Cindy Halbleib : Thank you for this presentation very informational..
janet Janet : Excellent presentation. Covered some unique things that are not always talked about, such as they can come anytime during "normal business" hours. Would love to have more webinars regarding FDA inspections.
Martin Núñez Nunez : FDQI?..
Setu Rajyaguru : CAn we have this presentation to make Quality team get trained.
Leonard : Thank you for a great presentation
Vasana Weerasinghe : Can you direct me to a place where I can see a sample regulatory program?
Stephen : Do you have a PDF of he slides? I came in a couple of minutes late... Stephen Bails Madison Hts MI
PREM SAGAR : Thank you for sharing knowledge about FDA and their inspection.
Charity : What is the best thing to do if FDA inspectors do not present form 842.
Muszalina Mustafa : can u share the slide
Eike : Where can I find a copy of the presentation shown in this seminar?
Lisa Petro : Has FDA actually contracted with the third parties, or are they just an option that a US producer can use in order to meet FSVP requirements?
Mohamed Sami : Thank you for the presentation.
Abd El-Rahman Ahmed El-Garhy : If I have fssc certificate it's enough or must have fsma to be have fda registration
Matthew Creswell : @Sarah that is good to know!!!
Stephanie Kopp : Thank you, Great information.
Muhammad Aslam Javaid : There are frequent upgradation into FDA regulations. How Can we follow these changes by FDA so we can implement in our area?
Paula Ferreira : About the recognition of third parties GFSI standards. IFS was not recognised. My company is certifified IFS, should we choose another standard?
Glen Todd : Can a food importer use the exporters 3rd party audit report to complete a hazard analysis for the FSVP program? Is this acceptable for the FDA?
Allan De Guzman : Question: During a US FDA inspection, do they ask for GSFI audit reports as reference during the FDA audit itself?
Charity : What is the best thing to do if the FDA does not present form 482
Giulia Grande PhD : do you have an outline for an excellent self-assessment program to check off all is completed ?
OLGA MARIA SANUDO FIGUEROA SANUDO FIGUEROA : Good morning watching from Mexico! thanks for this excelente presentation.
Phil Gao : Thank you.
Rakesh Patel : I am from India. How can I become FDA inspector in India?
Danielle Stubblebine : Do you recommend duplicate environmental swabbing to match FDA swabbing, if performed? Why/Why not?
Allan De Guzman : Allan De Guzman Question: During a US FDA inspection, do they ask for GSFI audit reports as reference during the FDA audit itself?
KADI Farid : Excellent presentation Thank you What inspection method has been adopted to evaluate food gold and especially vitamins used as food supplements, additives or for medical purposes (e.g. vitamin C)?
Rakesh Patel : I am from India. How can I become FDA inspector in India?
Carol Dyck : What is the foreign suppliers responsibility to the FSVP of their US customer?
michael madsen MADSEN : if we are under FSIS inpection and registered with FDA. will we need to have all requirements FDA is inspecting.
Jamie Adams : Is there recommended courses for FDQI or to become an FDQI can it be acquired by experience?
Klodian Dauti Dauti : Does FDA enforce/require expiration dates on the products?
Nereyda Laguna Laguna : Excelente presentation. Thank you!
Mahdaoui Djamal : Do the FDA inspection covers the food complaint handling procedures?
Paula Ferreira : Fantastic presentation! Thank you very much.
Robert Savage : How will the reorganization of FDA impact field inspections?
Allan De Guzman : Question: During a US FDA inspection, do they ask for GSFI audit reports as reference during the FDA audit itself?
Carmen : Excellent
Glen Todd : Does the FDA require mandatory lot#'s to be on food product master case labels?
Joshua Ayiri : Hello here, I am an SME on, Maize flour and peanut butter in Uganda, I need an HACCP plan sample to guide me in creating one for my company
Simone Mills : JANAAC- Jamaica National Agency for Accreditation is one such recognized body
Mahdaoui Djamal : Do the FDA inspection covers the out of process procedures and programs like food complaint handling procedures?
Sherry Byard Byard : Can you tell me more about requirements for border crossing with FSVP??
Janelle Nicholas Nicholas : Thank you
Lisa Petro : Third party auditors are qualified, but is FDA actually contracting with them to do regulatory inspections?
Radojka Barycki : Great webinar. Thank you!
Martin Núñez Nunez : Thanks for this webinar
Guadalupe Santana Santana : Excellent webinar! Thank you!
Joumana Bteich : Great presentation!
Sheneel Williams : How important is it to implement hazard analysis program?
Arvind Kumar : Thankyou for this valuable information
Allan De Guzman : Question: During a US FDA inspection, do they ask for GSFI audit reports as reference during the FDA audit itself?
Mohammed ARAB : "is mandatory to applly PART 121 MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION or can we use other guideline like GFSI?"
Toni Widger : Great Presentation!
Mark Reyes : Can your FSVP be owned by your corporate office, which is located at a different location?
Giulia Grande PhD : what are key takeaways to ensure our site is prepared?
Alicia Albright Albright : Thank you
Ayman Eshra : Thanks
Christopher Fiyado : Execllent. Thank you!
Atilio Guzman : Thank you, it was great
Deborah Lyons-Garcia Lyons-Garcia : thank you
Dzung Nguyen Mattson : Thank you
Eva VILLARREAL : Thank you! Great presentation!
Mark Reyes : Thank You!!!
Vivette Gooden Gooden : Excellent presentation. Thank you
Dea Lopez Lopez : thank you was good to see you again
Mahdaoui Djamal : thank you sir
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